FDA-Device2016-06-01Class II
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Roche Molecular Systems, Inc.
Hazard
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
Sold states
Hungary
Affected count
8 kits
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1830-2016Don't want to check this manually?
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